NCT00036062已完成1 期
A Phase II Study to Determine the Efficacy and Safety of Sivelestat in Subjects With Acute Lung Injury
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 109
研究概览
简要总结
The purpose of this study is to determine whether sivelestat will reduce the amount of time a patient must spend on a ventilator and/or increase the chance of survival of patients with acute lung injury.
详细描述
Acute lung injury often develops as a result of severe infection, sepsis, severe injuries, inhalation of foreign substances into the lungs, or pneumonia. The tissues and blood vessels in the lungs become inflamed, and the body does not receive enough oxygen. Patients with this condition are placed on a ventilator to assist with breathing.
Patients entered into this study will be randomly assigned to one of two treatment groups: a sivelestat group or a placebo group. Once entered into the study, patients are monitored for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •show evidence of acute lung injury
- •be on mechanical ventilation
排除标准
- •have undergone certain organ transplants
- •have severe underlying medical problems
- •be unlikely to survive
- •be pregnant or breast-feeding
研究者
研究点 (109)
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